Supply Chain Lead

Avalo Therapeutics; Chesterbrook (PA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Avalo Therapeutics seeks a strategic, hands-on Supply Chain Lead to guide global clinical supply operations from early development to late-stage studies. You will oversee forecasting, packaging, labeling, IRT, inventory, and global distribution while partnering with CMC, Quality, Regulatory, and Clinical Ops to ensure uninterrupted drug supply.

Based in a hybrid setup with cross-functional collaboration, this role requires deep knowledge of GDP, cGMP, and global logistics to support Avalo's

Qualifications

• Bachelor’s degree in a relevant field and minimum 5 years in the pharmaceutical industry with a focus in clinical supplies and global supply chain management.
• Experience in SD&OP activities supporting clinical trial supply.
• Exceptional project management, analytical, and problem-solving skills with a demonstrated ability to manage multiple priorities.
• Strong understanding of the drug supply, distribution and packaging process.
• Demonstrated experience in strategic supply chain and supplier relationship management.
• Knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to GDPs and local country drug shipment regulations.

Responsibilities

• Lead end-to-end global clinical supply operations across early- through late-phase clinical studies, ensuring reliable supply throughout the study lifecycle.
• Own clinical supply forecasting and demand planning, translating enrollment, dosing, treatment duration, study timelines, and protocol changes into manufacturing, packaging, labeling, and distribution requirements.
• Develop and execute integrated clinical supply plans and manufacturing schedules, ensuring drug product, materials, and resources are available to meet program and study milestones.
• Lead packaging, labeling, IRT, SKU planning and release, inventory management, global distribution, returns, reconciliation, and destruction activities through third-party providers.
• Drive S&OP/SD&OP activities for clinical programs, balancing demand, manufacturing capacity, inventory, study assumptions, and program timelines.
• Establish strategic direction for clinical supply outsourcing and lead external vendor relationships, including packaging and labeling providers, logistics partners, depots, and other third-party supply organizations.
• Monitor inventory, manufacturing and supply metrics, release timelines, and key milestones; proactively identify supply risks, shortages, or delays and implement mitigation and contingency plans.
• Serve as the clinical supply subject matter expert and primary point of contact for supply planning, operational issues, and ad hoc supply chain analyses.
• Partner closely with Clinical Operations, CMC, Quality, Regulatory, and other cross-functional stakeholders to align clinical supply strategy with study execution and broader development plans.
• Ensure clinical supply operations comply with applicable cGMP, GCP, GDP, international shipping, customs, and country-specific regulatory requirements.
• Build and scale clinical supply capabilities, processes, systems, vendor strategies, and operating practices as Avalo advances into larger, global, and increasingly complex late-stage clinical studies.

Skills

Team leadership

Problem solving

Forecasting

Cross-functional collaboration

Communication skills

Resource allocation

Negotiation

Analytical thinking

Education

Bachelor’s degree in Business Administration, Pharmacy, Biology or related science

Job description

At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.

We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.

Position Summary:

Avalo Therapeutics is seeking a strategic and hands-on Supply Chain Lead to lead global clinical supply operations across programs ranging from early development through late-stage clinical studies. This is a highly visible opportunity to help build and scale clinical supply capabilities as Avalo and its pipeline continue to grow.

As a key member of the CMC Biologics team, you will oversee the end-to-end clinical supply lifecycle, including demand forecasting, IRT, packaging and labeling, inventory management, global distribution and logistics, and external vendor oversight. You will partner cross-functionally to anticipate supply needs, manage risk, and ensure reliable drug supply to support our global clinical programs and the patients they serve.

Essential Duties and Responsibilities:

• Lead end-to-end global clinical supply operations across early- through late-phase clinical studies, ensuring reliable supply throughout the study lifecycle.
• Own clinical supply forecasting and demand planning, translating enrollment, dosing, treatment duration, study timelines, and protocol changes into manufacturing, packaging, labeling, and distribution requirements.
• Develop and execute integrated clinical supply plans and manufacturing schedules, ensuring drug product, materials, and resources are available to meet program and study milestones.
• Lead packaging, labeling, IRT, SKU planning and release, inventory management, global distribution, returns, reconciliation, and destruction activities through third-party providers.
• Drive S&OP/SD&OP activities for clinical programs, balancing demand, manufacturing capacity, inventory, study assumptions, and program timelines.
• Establish strategic direction for clinical supply outsourcing and lead external vendor relationships, including packaging and labeling providers, logistics partners, depots, and other third-party supply organizations.
• Monitor inventory, manufacturing and supply metrics, release timelines, and key milestones; proactively identify supply risks, shortages, or delays and implement mitigation and contingency plans.
• Serve as the clinical supply subject matter expert and primary point of contact for supply planning, operational issues, and ad hoc supply chain analyses.
• Partner closely with Clinical Operations, CMC, Quality, Regulatory, and other cross-functional stakeholders to align clinical supply strategy with study execution and broader development plans.
• Ensure clinical supply operations comply with applicable cGMP, GCP, GDP, international shipping, customs, and country-specific regulatory requirements.
• Build and scale clinical supply capabilities, processes, systems, vendor strategies, and operating practices as Avalo advances into larger, global, and increasingly complex late-stage clinical studies.

Additional Skills, Knowledge, and/or Abilities:

• Demonstrate a strong consistent display of team behavior by actively participating in project-related teams and is accountable for supply related component.
• Has a high level of problem-solving skills and uses them to monitor key milestones in the global clinical supply process.
• Recommends and implements ways to improve the efficiency of clinical supply processes.
• Experience in SD&OP activities supporting clinical trial studies
• Excellent interpersonal skills. Self-motivated with a proven ability to organize project activity to meet multiple project timelines.
• Demonstrated project planning skills to make optimum use of resources and to meet timelines. Effective communication and knowledge of how to impact and influence internal and external partners.
• Strong oral, written, verbal, and interpersonal communication skills.
• Able to present data and analyses in an organized, clear, and concise manner.
• Ability to effectively communicate and persuade others to accomplish clinical supply goals and objectives.
• Ability to forecast and allocate resources to manage clinical supply programs with focus on meeting the program objectives.

Education & Experience:

• Bachelor’s degree in Business Administration, Pharmacy, Biology or related science with minimum 5 years of experience in the pharmaceutical industry with a focus in clinical supplies and global supply chain management.
• Experience in SD&OP activities supporting clinical trial supply.
• Exceptional project management, analytical, and problem-solving skills with a demonstrated ability to manage multiple priorities.
• Strong understanding of the drug supply, distribution and packaging process.
• Demonstrated experience in strategic supply chain and supplier relationship management.
• Knowledge of the global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.
• Advanced knowledge of fundamental concepts of materials requirements, planning, and procurement including: inventory management, Supply Demand and Operations Planning, expediting, third party supplier work order reviews, contract updates, and order placement
• Advanced knowledge of the full range of concepts, practices in the materials planning field, including reorder point planning, contract communication/execution
• Capability to work in a changing environment and beyond pre-defined processes.
• Demonstrated success working effectively with cross-functional teams to get results through effective skills in negotiation, priority management communication (works in transparency), problem solving and decision-making.
• Knowledge of supply chain concepts and practices in Biopharmaceutical industry
• Knowledge of international customs & trade, taxation, transfer pricing and cGMP regulatory requirements

Location:

This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1-4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next-generation anti-IL-1β mAb. For more information about Avalo, please visitwww.avalotx.com .